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Table 3 Participant timeline

From: The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19

Study period Screening Baseline Treatment Follow-up
Study day (± window) 0-1 1 2 3 4 5 6 7 10 11-27 28 (±3)
ELIGIBILITY            
(Deferred) Informed consent X           
Demographics X           
Relevant medical history X           
SARS-CoV-2 diagnostic test review X           
Assess ARDS diagnosis and severity X           
Inclusion and exclusion criteria X           
STUDY INTERVENTION            
Randomization   X          
IMP administration   X X X X X X X    
Treatment with SoC X X X X X X X X X X X
STUDY PROCEDURES            
12-lead Electrocardiogram X X X   X    X X   
Height and weight   X        X   
Targeted physical examination   X X X X X X X    
Vital signs: temperature, pulse rate, blood pressure, respiratory rate, SpO2 and FiO2 X X X X X X X X X   
Placement of central venous catheter and PiCCO catheter X           
EVLWi and PVPi   X X   X    X    
Mechanical ventilation parameters(i)   X X   X    X X   X
Arterial blood gas   X X   X    X X   
SOFA score and OI   X X   X    X X   X
Clinical status   X X X X X X X X   X
PK sampling   X X(m)   X(m)    X(m)    
Blood, plasma and serum sampling for biomarker studies   X X   X    X X   
Thoracic ultrasound (optional)   X    X    X    
Targeted medication review (including use of vasopressors)   X X X X X X X   X X
Adverse event evaluation   X X X X X X X X X X
SAFETY LABORATORY            
Hematology, chemistry, liver function tests, coagulation X X X   X    X X   
Pregnancy test for females of childbearing potential X